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Faries MB , Thompson JF , Cochran AJ , Andtbacka RH , Mozzillo N , Zager JS , Jahkola T , Bowles TL , Testori A , Beitsch PD , Hoekstra HJ , Moncrieff M , Ingvar C , Wouters Mwjm , Sabel MS , Levine EA , Agnese D , Henderson M , Dummer R , Rossi CR , Neves RI , Trocha SD , Wright F , Byrd DR , Matter M , Hsueh E , MacKenzie-Ross A , Johnson DB , Terheyden P , Berger AC , Huston TL , Wayne JD , Smithers BM , Neuman HB , Schneebaum S , Gershenwald JE , Ariyan CE , Desai DC , Jacobs L , McMasters KM , Gesierich A , Hersey P , Bines SD , Kane JM , Barth RJ , McKinnon G , Farma JM , Schultz E , Vidal-Sicart S , Hoefer RA , Lewis JM , Scheri R , Kelley MC , Nieweg OE , Noyes RD , Hoon DSB , Wang HJ , Elashoff DA , Elashoff RM
Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma
N Engl J Med. 2017 Jun 08;376(23) :2211-2222
PMID: 28591523    PMCID: PMC5548388    URL: https://www.ncbi.nlm.nih.gov/pubmed/28591523
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Abstract
BACKGROUND: Sentinel-lymph-node biopsy is associated with increased melanoma-specific survival (i.e., survival until death from melanoma) among patients with node-positive intermediate-thickness melanomas (1.2 to 3.5 mm). The value of completion lymph-node dissection for patients with sentinel-node metastases is not clear. METHODS: In an international trial, we randomly assigned patients with sentinel-node metastases detected by means of standard pathological assessment or a multimarker molecular assay to immediate completion lymph-node dissection (dissection group) or nodal observation with ultrasonography (observation group). The primary end point was melanoma-specific survival. Secondary end points included disease-free survival and the cumulative rate of nonsentinel-node metastasis. RESULTS: Immediate completion lymph-node dissection was not associated with increased melanoma-specific survival among 1934 patients with data that could be evaluated in an intention-to-treat analysis or among 1755 patients in the per-protocol analysis. In the per-protocol analysis, the mean (+/-SE) 3-year rate of melanoma-specific survival was similar in the dissection group and the observation group (86+/-1.3% and 86+/-1.2%, respectively; P=0.42 by the log-rank test) at a median follow-up of 43 months. The rate of disease-free survival was slightly higher in the dissection group than in the observation group (68+/-1.7% and 63+/-1.7%, respectively; P=0.05 by the log-rank test) at 3 years, based on an increased rate of disease control in the regional nodes at 3 years (92+/-1.0% vs. 77+/-1.5%; P<0.001 by the log-rank test); these results must be interpreted with caution. Nonsentinel-node metastases, identified in 11.5% of the patients in the dissection group, were a strong, independent prognostic factor for recurrence (hazard ratio, 1.78; P=0.005). Lymphedema was observed in 24.1% of the patients in the dissection group and in 6.3% of those in the observation group. CONCLUSIONS: Immediate completion lymph-node dissection increased the rate of regional disease control and provided prognostic information but did not increase melanoma-specific survival among patients with melanoma and sentinel-node metastases. (Funded by the National Cancer Institute and others; MSLT-II ClinicalTrials.gov number, NCT00297895 .).
Notes
1533-4406 Faries, Mark B Thompson, John F Cochran, Alistair J Andtbacka, Robert H Mozzillo, Nicola Zager, Jonathan S Jahkola, Tiina Bowles, Tawnya L Testori, Alessandro Beitsch, Peter D Hoekstra, Harald J Moncrieff, Marc Ingvar, Christian Wouters, Michel W J M Sabel, Michael S Levine, Edward A Agnese, Doreen Henderson, Michael Dummer, Reinhard Rossi, Carlo R Neves, Rogerio I Trocha, Steven D Wright, Frances Byrd, David R Matter, Maurice Hsueh, Eddy MacKenzie-Ross, Alastair Johnson, Douglas B Terheyden, Patrick Berger, Adam C Huston, Tara L Wayne, Jeffrey D Smithers, B Mark Neuman, Heather B Schneebaum, Schlomo Gershenwald, Jeffrey E Ariyan, Charlotte E Desai, Darius C Jacobs, Lisa McMasters, Kelly M Gesierich, Anja Hersey, Peter Bines, Steven D Kane, John M Barth, Richard J McKinnon, Gregory Farma, Jeffrey M Schultz, Erwin Vidal-Sicart, Sergi Hoefer, Richard A Lewis, James M Scheri, Randall Kelley, Mark C Nieweg, Omgo E Noyes, R Dirk Hoon, Dave S B Wang, He-Jing Elashoff, David A Elashoff, Robert M R01 CA189163/CA/NCI NIH HHS/United States P01 CA029605/CA/NCI NIH HHS/United States Clinical Trial, Phase III Comparative Study Journal Article Multicenter Study Randomized Controlled Trial United States N Engl J Med. 2017 Jun 8;376(23):2211-2222. doi: 10.1056/NEJMoa1613210.